Subarachnoid HemorrhagePhase 3SCILNCT03249207
SC IL-1Ra in SAH - Phase III Trial (SCIL)
A Phase 3 study testing IL-1Ra in people with Subarachnoid Hemorrhage, run by University of Manchester at 17 sites in United Kingdom.
Trial summary
This phase III trial will establish whether IL-1Ra, with sub-cutaneous (SC) administration twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (aSAH), improves clinical outcome as measured by ordinal shift in mRS at 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- IL-1Ra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 612 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- 11 Oct 2018to Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CT positive spontaneous SAH admitted to a participating neurosurgical centre where written informed consent can be obtained and study drug can be administered within 72 hours of ictus.
- No concomitant health problems that, in the opinion of the PI or designee, would interfere with participation, administration of study drug or assessment of outcomes including safety.
- Willing and able to give informed consent or consent available from a patient representative for trial inclusion including agreement in principle to receive study drug and undergo all study assessments.
- Male or female aged 18 years or above.
Who cannot join
- Unconfirmed or uncertain diagnosis of spontaneous SAH.
- Known active tuberculosis or active hepatitis.
- Known active malignancy.
- Known Still's Disease
- Neutropenia (ANC <1.5 x 109/L ).
- Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) < 30 ml/minute) documented in the last 3 months prior to this SAH.
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- Live vaccinations within the last 10 days of this SAH.
- Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.
- Current treatment with TNF antagonists.
- Known to have participated in a clinical trial of an investigational agent or device in the 30 days prior to ictus.
- Known to have participated in a clinical trial of an investigational agent or device within 5 half-lives (of the previous agent or device) prior to ictus.
- Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant
- Clinically significant serious concurrent medical condition, pre morbid illnesses, or concurrent serious infection, at the PI's (or designee's) discretion, which could affect the safety or tolerability of the intervention.
- Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC
- Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. E.coli derived protein).
- Current treatment with IL-6 or IL-1 inhibitors or drugs affecting the IL-1 axis.
- History of DRESS syndrome.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Royal Sussex County Hospital
Brighton, BN2 5BE
Southmead Hospital
Bristol, BS10 5NB
Addenbrookes Hospital
Cambridge, CB2 0QQ
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Leeds General Infirmary
Leeds, Yorkshire, LS1 3EX
The Walton Centre
Liverpool, L9 7LJ
Royal London Hospital
London, E1 1FR
St George's Hospital
London, SW17 0QT
Charing Cross Hospital
London, W6 8RF
National Hospital for Neurology and Neurosurgery, Queen Square
London, WC1N 3BG
Northern Care Alliance NHS Foundation Trust
Manchester
Queens Medical Centre
Nottingham, NG7 2UH
Derriford Hospital
Plymouth, Devon, PL6 8DH
Royal Preston Hospital
Preston, PR2 9HT
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
Southampton General Hospital
Southampton, SO16 6YD
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
About this study
Official title: Does Interleukin-1 Receptor Antagonist Improve Outcome Following Aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III Trial
This phase III trial will establish whether IL-1Ra, with sub-cutaneous (SC) administration twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (aSAH), improves clinical outcome as measured by ordinal shift in mRS at 6 months.
Patients with SAH transferred to a neurosurgical centre will be identified and approached for study participation. Following consent, patients will be randomised to receive either IL-1Ra or placebo for a maximum of 21 days from onset of symptoms. Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment. Blood samples for plasma IL-6 will be obtained prior to randomisation and at day 3-5 post randomisation for IL-6 \& IL-1 measurement. Safety will be measured at 30 days post randomisation and outcome assessed at 6 months post randomisation.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- IL-1Ra, IL-1Ra Placebo
- Keywords
- Aneurysmal
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-1RaDrug
Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
IL-1Ra PlaceboDrug
Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
| Study group | Role | What they receive |
|---|---|---|
| IL-1Ra twice daily | Active comparator | Not described Receives: Drug: IL-1Ra |
| Placebo twice daily | Placebo comparator | Not described Receives: Drug: IL-1Ra Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ordinal shift in modified Rankin Score (mRS)
Measured: 6 months post randomisation
Secondary outcomes (3)
Measurement of mood using HADS
Measured: 6 months post randomisation
Measurement of fatigue using Fatigue score
Measured: 6 months post randomisation
Measurement of quality of life using EQ-5D-5L score
Measured: 6 months post randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start11 Oct 2018
- Primary completionApr 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 612 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Clinical Trials Unit, Manchester, Northern Care Alliance NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Andrew King, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249207
- Sponsor's protocol ID
- R121178
- Acronym
- SCIL
- Status last verified
- Oct 2023
- First submitted
- 9 Aug 2017
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Interleukin-1 Receptor Antagonist Improve Outcome Following Aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III Trial
- ClinicalTrials.gov ID
- NCT03249207
- Acronym / sponsor ID
- SCIL / R121178
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Aneurysmal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 612 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Clinical Trials Unit, Manchester, Northern Care Alliance NHS Foundation Trust
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III trial will establish whether IL-1Ra, with sub-cutaneous (SC) administration twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (aSAH), improves clinical outcome as measured by ordinal shift in mRS at 6 months.
Patients with SAH transferred to a neurosurgical centre will be identified and approached for study participation. Following consent, patients will be randomised to receive either IL-1Ra or placebo for a maximum of 21 days from onset of symptoms. Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment. Blood samples for plasma IL-6 will be obtained prior to randomisation and at day 3-5 post randomisation for IL-6 \& IL-1 measurement. Safety will be measured at 30 days post randomisation and outcome assessed at 6 months post randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL-1Ra twice daily | Active comparator | Drug: IL-1Ra |
| Placebo twice daily | Placebo comparator | Drug: IL-1Ra Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with CT positive spontaneous SAH admitted to a participating neurosurgical centre where written informed consent can be obtained and study drug can be administered within 72 hours of ictus.
- No concomitant health problems that, in the opinion of the PI or designee, would interfere with participation, administration of study drug or assessment of outcomes including safety.
- Willing and able to give informed consent or consent available from a patient representative for trial inclusion including agreement in principle to receive study drug and undergo all study assessments.
- Male or female aged 18 years or above.
Key exclusion criteria (17 listed)
- Unconfirmed or uncertain diagnosis of spontaneous SAH.
- Known active tuberculosis or active hepatitis.
- Known active malignancy.
- Known Still's Disease
- Neutropenia (ANC <1.5 x 109/L ).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IL-1RaDoses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre). | Drug | IL-1Ra twice daily |
| IL-1Ra PlaceboDoses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre). | Drug | Placebo twice daily |
Primary outcome
Ordinal shift in modified Rankin Score (mRS)
Time frame: 6 months post randomisation
3 secondary outcomes
Measurement of mood using HADS
Time frame: 6 months post randomisation
Measurement of fatigue using Fatigue score
Time frame: 6 months post randomisation
Measurement of quality of life using EQ-5D-5L score
Time frame: 6 months post randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew King principal investigator
University of Manchester
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IL-1Ra in people with Subarachnoid Hemorrhage, run by University of Manchester at 17 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ordinal shift in modified Rankin Score (mRS) (time frame: 6 months post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.